FDA 510(k) Application Details - K171879

Device Classification Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic   More FDA Info for this Device
510(K) Number	K171879
Device Name	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant	Founders Science Group, LLC 30 Robert W. Boyden Road Suite A1000 Taunton, MA 02780 US Other 510(k) Applications for this Company
Contact	Ronald M. Gurge Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2017
Decision Date	10/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review